[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589350":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":59,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":89,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Women and Infants Hospital of Rhode Island","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Typically prescribed oral antibiotic prophylaxis","ACTIVE_COMPARATOR","Typically prescribed oral antibiotic prophylaxis for the purposes of this study is defined as oral antibiotics that are routinely prescribed following BOTOX-A injections for UTI prophylaxis. Given known heterogeneity in antibiotic prophylaxis type and duration as well as the lack of standardized antibiotic recommendations for intradetrusor BOTOX-A injections, the choice of antibiotic prophylaxis is deferred to the physician performing the BOTOX-A injections. The duration of treatment will be standardized to three days, based off previous studies.",[13],"Drug: Typically prescribed oral antibiotic prophylaxis",{"label":15,"type":16,"description":17,"interventionNames":18},"Methenamine hippurate prophylaxis","EXPERIMENTAL","Participants in the experimental arm will receive methenamine hippurate 1 gram by mouth twice daily for three days.",[19],"Drug: Methenamine Hippurate",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Methenamine Hippurate","Drug: Methenamine hippurate 1 gram by mouth twice daily for three days.",[15],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"Drug: typically prescribed oral antibiotic prophylaxis following intradetrusor BOTOX-A injections. This includes, but is not limited to, antibiotic medications such as nitrofurantoin, amoxicillin\u002Fclavulanic acid, and trimethoprim\u002Fsulfamethoxazole. Dosage will be determined per usual care. Duration of treatment will be standardized to three days.",[9],[31],"Oral antibiotics",[33],{"name":34,"affiliation":35,"role":36},"Vivian Sung, MD, MPH","Women & Infants Hospital","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Colin Russell, MD, MPH","CONTACT","401-453-7560","CoRussell@wihri.org",{"name":44,"role":40,"phone":41,"phoneExt":26,"email":45},"Kyle Wohlrab, MD","KWohlrab@CareNE.org",[47],{"facility":35,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":26},"Providence","Rhode Island","02903","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-71.41283,41.82399,{"lat":57,"lon":56},{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100589350","phase-4-methenamine-hippurate-following-intradetrusor-onabotulinumtoxina-injection-100589350",false,"NCT06953271","Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection","Methenamine Hippurate Compared to Typical Antibiotic Prophylaxis in the Prevention of Urinary Tract Infection Following Intradetrusor OnabotulinumtoxinA Injection for Treatment of Overactive Bladder: a Randomized Controlled Non-Inferiority Trial","META","Inclusion Criteria:\n\n* 18 years of age or older\n* undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder\n\nExclusion Criteria:\n\n* cisgender male individuals\n* neurogenic reasons for bladder symptoms (i.e. spinal cord injury, multiple sclerosis, etc.)\n* known allergy and\u002For contraindication to methenamine hippurate\n* currently already taking methenamine hippurate at the time of the procedure\n* taking antibiotics for any reason on the day of their BOTOX-A procedure\n* positive UTI at time of procedure (positive dip at time of procedure)\n* history of bladder cancer\n* history of pelvic radiation\n* surgically altered detrusor muscle\n* pre-procedural need for catheterization\n* diagnosis of Interstitial Cystitis\u002FPainful Bladder Syndrome (IC\u002FPBS)\n* pregnant or lactating individuals","FEMALE","18 Years",{"count":72,"type":73},164,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","The goal of this clinical trial is to compare methenamine hippurate prophylaxis to routine antibiotic prophylaxis following onabotulinumtoxinA (BOTOX-A) injections in women with overactive bladder (OAB). Participants will be randomly selected to receive one of the two post-procedural prophylaxis medications. The primary outcome measure will be urinary tract infection (UTI) rates within 30 days from the BOTOX-A procedure. Secondary outcomes will assess patient satisfaction with the two post-procedural prophylaxis medications.",[79,80],"Overactive Bladder (OAB)","Urinary Tract Infection (Diagnosis)",[82,83,84,85,86,87,88],"Overactive Bladder","onabotulinumtoxinA","Methenamine","Urinary Tract Infection","BOTOX-A","UTI","OAB","NOT_YET_RECRUITING","2025-04-23",{"date":92,"type":93},"2025-05-01","ACTUAL",{"date":95,"type":73},"2025-05-15",{"date":97,"type":73},"2027-01-01",{"name":5,"class":6},1]